This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,600
Participants will receive IV trontinemab.
Participants will receive IV placebo.
Irvine Center for Clinical Research
Irvine, California, United States
RECRUITINGSyrentis Clinical Research
Santa Ana, California, United States
RECRUITINGK2 Medical Research, LLC
Maitland, Florida, United States
Time to Progression, defined as confirmed Clinical Dementia Rating - Global Score (CDR-GS) > 0
Time frame: Baseline up to approximately 6 years
Change from Baseline through Week 216 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Time frame: Baseline through Week 216
Change from Baseline through Week 216 in Free and Cued Selective Reminding Test (FCSRT) total recall score
Time frame: Baseline through Week 216
Change from Baseline through Week 216 in Digit Symbol Substitution Test (DSST) coding score
Time frame: Baseline through Week 216
Change from Baseline through Week 216 in Cognitive Function Instrument (CFI) study partner, total score
Time frame: Baseline through Week 216
Change from Baseline through Week 216 in Category fluency total score
Time frame: Baseline through Week 216
Change from Baseline through Week 216 in Mini-Mental State Examination (MMSE) total score
Time frame: Baseline through Week 216
Change from Baseline through Week 216 in Wechsler Memory Scale, Logical Memory II Delayed Paragraph Recall (WMS LM II [DR]) score
Time frame: Baseline through Week 216
Change from Baseline through Week 216 in Amsterdam Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV) study partner, total score
Time frame: Baseline through Week 216
Reference Study ID Number: WN46072 https://forpatients.roche.com
CONTACT
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Basil Clinical
Laurelton, New York, United States
RECRUITINGToronto Memory Program
Toronto, Ontario, Canada
RECRUITINGXuanwu Hospital, Capital Medical University
Beijing, China
RECRUITINGSurrey and Borders NHS Foundation Trust
Chertsey, United Kingdom
RECRUITINGChange from Baseline through Week 216 in Trail Making Test (TMT)
Time frame: Baseline through Week 216
Time to progression to adjudicated mild cognitive impairment (MCI) diagnosis
Time frame: Baseline up to approximately 6 years
Incidence of adverse events
Time frame: Baseline up to approximately 6 years
Frequency of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) magnetic resonance imaging (MRI) findings
Time frame: Baseline up to approximately 6 years
Severity of ARIA-E and ARIA-H MRI findings
Time frame: Baseline up to approximately 6 years
Frequency of infusion-related reactions (IRRs)
Time frame: Baseline up to approximately 6 years
Severity of IRRs
Time frame: Baseline up to approximately 6 years
Incidence of anti-drug antibodies (ADAs) to trontinemab
Time frame: Baseline up to approximately 6 years
Change from baseline through Week 216 in brain amyloid load, as measured by amyloid positron emission tomography (PET) scan
Time frame: Baseline through Week 216
Change from baseline through Week 216 in blood biomarker phosphorylated tau 217 (pTau217)
Time frame: Baseline through Week 216
Change from baseline through Week 216 in blood biomarker glial fibrillar acidic protein (GFAP)
Time frame: Baseline through Week 216